FDA expanded the indication for the Gore Viabahn VBX balloon expandable endoprosthesis, Gore announced on October 14. The device is now indicated to maintain visceral artery perfusion as a bridging stent in fenestrated endovascular aortic repair with 6 to 8 mm fenestrations, and in branched repair with 6 to 8 mm branches at least 10 mm long.
The label limits bridging use to aortic endograft systems where safety and effectiveness have been demonstrated. Europe granted the same indication in 2025. VBX keeps its existing iliac indication for reference vessel diameters of 5 to 13 mm and lesion lengths up to 110 mm.
Three year results from the core lab analyzed, multicenter EMBRACE registry, presented at the European Society for Vascular Surgery annual meeting, supported the expansion. In 103 FEVAR patients and 208 target vessels, vessel level primary patency was 97.5 percent and freedom from target vessel instability 93.9 percent. In 165 BEVAR patients and 454 target vessels, the figures were 94.0 percent and 88.4 percent.
Gore has sold more than 600,000 VBX units worldwide since the 2017 US launch, so this is a label catching up with how surgeons already use the device. The evidence package is the part worth copying: vessel level endpoints, adjudicated by a core lab, reported at three years rather than one.